Lattice

ABSTRACT

The invention relates to medical devices and methods of using them. The devices are prostheses which can be percutaneously deliverable with (or on) an endovascular catheter or via other surgical or other techniques and then expanded. The prostheses are configured to have a lattice resistant to dilation and creep, which is defined by a plurality of openings. The prosthesis may also optionally have a stent disposed proximal to the lattice. In exemplary embodiments, the fluoropolymer is expanded polytetrafluoroethylene. The composite materials exhibit high elongation while substantially retaining the strength properties of the fluoropolymer membrane. In at least one embodiment, the lattice is made of a composite material that includes a least one fluoropolymer membrane including serpentine fibrils and an elastomer. A lattice including a generally tubular member formed of a composite material including a least one fluoropolymer membrane containing serpentine fibrils and an elastomer is also provided.

CROSS-REFERENCE TO A RELATED APPLICATION

This application claims priority to U.S. Patent Application No.61/598,828 filed on Feb. 14, 2012, and is a Continuation-In-Part of U.S.patent application Ser. No. 13/298,060 filed on Nov. 16, 2011, which, inturn, claims priority under 35 U.S.C. 119(e) to U.S. ProvisionalApplication No. 61/433,069 filed on Jan. 14, 2011 and U.S. ProvisionalApplication No. 61/523,115 filed on Aug. 12, 2011, the contents of allnoted applications are incorporated herein in their entireties.

FIELD OF THE INVENTION

The invention relates generally to medical implants for supporting,maintaining, or repairing a lumen, passageway or opening in a livingbody and to methods of using them. In particular, the invention relatesto medical devices that are designed to be inserted endoluminally into abody.

BACKGROUND OF THE INVENTION

Medical stents are generally known. One use for medical stents is toexpand a body lumen, such as a blood vessel, which has contracted indiameter through, for example, the effects of lesions called atheroma orthe occurrence of cancerous tumors. Atheroma refers to lesions withinarteries that include plaque accumulations that can obstruct blood flowthrough the vessel. Over time, the plaque can increase in size andthickness and can eventually lead to clinically significant narrowing ofthe artery, or even complete occlusion. When expanded against the bodylumen, which has contracted in diameter, the medical stents provide atube-like support structure inside the body lumen. Stents, incombination with coverings, also can be used for the endovascular repairof aneurysms, an abnormal widening or ballooning of a portion of a bodylumen which can be related to weakness in the wall of the body lumen.Various stent designs are known in the art. Stents typically aretubular, and are expandable or self-expand from a relatively smalldiameter to a larger diameter.

SUMMARY OF THE INVENTION

A prosthesis according to this application is suitable for implantationinto various body vessels or openings and can be adjusted in accordanceto the size (length or diameter) of said body vessel or opening.Further, the prosthesis in accordance with the instant invention is anendovascular prosthesis resistant to dilation and creep that can beconfigured to radially or longitudinally expand under the action of thedistensive force in a sloped or in a stepped manner. The prosthesis isprovided with or without one or more stents, one or more grafts, or acombination of stents and grafts.

In one embodiment, a prosthesis is provided with a lattice, whichdefines a plurality of openings. The lattice is resistant to dilationand creep and can be configured to radially expand under the action ofthe distensive force in a sloped or in a stepped manner. The latticecomprises at least two circumferential segments. The circumferentialsegments are oriented at an angle of between about 45° and about 90°with respect to the longitudinal axis of the prosthesis. When notcompacted the prosthesis and lattice expands radially into an enlargedfirst diametrical dimension, wherein the full expansion of theprosthesis is constrained by the lattice. At least one circumferentialsegment of the lattice is resistant to further expansion. The prosthesisand lattice can be adjusted to a further enlarged second diametricaldimension when distensive force is applied to the lattice and thecircumferential segment resistant to further expansion is plasticallydeformed (i.e. stretch with little or no recoil) or ruptured. If thecircumferential segment is plastically deformed, the lattice expands ina sloped manner. If the circumferential segment ruptures, the latticeexpands in a stepped manner. Once the prosthesis expands radially intoan enlarged second diametrical dimension, at least one circumferentialsegment of the lattice is resistant to further expansion. An embodimentcomprises at least two continuous longitudinal segments, and at leasttwo continuous circumferential segments, wherein the longitudinal andcircumferential segments define the plurality of openings. In such anembodiment, the longitudinal segments are substantially parallel to alongitudinal axis of the prosthesis.

In another embodiment, a prosthesis has a lattice that can be configuredto longitudinally expand under the action of the distensive force in asloped or in a stepped manner in which longitudinal segments areplastically deformed or ruptured. In another embodiment, said prosthesishas a lattice that can be configured to radially and longitudinallyexpand.

In another embodiment, a prosthesis has a multi-layer lattice, whichdefines a plurality of openings. The lattice is resistant to dilationand creep and can be configured to radially expand under the action ofthe distensive force in a sloped or in a stepped manner. The latticeforms a unitary tubular structure having a first expanded diameter whenthe prosthesis is not radially constrained. At least one layer withinthe lattice is under load when the prosthesis is not radiallyconstrained. Such layer is resistant to further radial expansion of theprosthesis. The prosthesis can be adjusted to a second expanded diameterthat is greater than the first diameter when a distensive force isapplied to the lattice. At a prescribed pressure, the distensive forcecauses the layer of the lattice that is resistant to further radialexpansion of the prosthesis to rupture or plastically deform. If thelayer is plastically deformed, the lattice expands in a sloped manner.If the layer is ruptured, the lattice expands in a stepped manner. Thelattice then expands radially to the second expanded diameter. At leastone layer within the lattice is under load at the second expandeddiameter. Such layer is resistant to further radial expansion of theprosthesis. The number of layers having varied expanded diameters withinthe lattice is not particularly limited. The expansion using thedistensive force with prescribed pressure can continue to rupture orplastically deform individual layers or several layers at the same timeif they all have the same expanded diameter until all the layers areruptured or plastically deformed and the indwelling prosthesis isallowed to achieve its full, unconstrained diameter. Alternatively, theprosthesis can reach a built in “hard-stop” at which point no furtherexpansion is allowed by the lattice.

In another embodiment, a prosthesis has a multi-layer lattice that canbe configured to longitudinally expand in either a stepped or a slopedmanner, yet resist dilation or creep. In another embodiment, aprosthesis has a multi-layer lattice that can be configured to radiallyand/or longitudinally expand. In another embodiment, a prosthesis has amulti-layer lattice that can be configured to radially and/orlongitudinally expand in partially stepped and partially sloped mannerin which, for example, the segments in one layer are broken and thesegments in another layer are plastically deformed.

In another embodiment, a prosthesis is an accessory prosthesis having alattice with or without a stent frame at one or both ends. The stentframe may be balloon expandable or self-expanding. The lattice defines aplurality of openings and has at least two continuous longitudinalsegments and at least two continuous circumferential segments. Thelattice can be configured to radially and/or longitudinally expand in astepped or a sloped manner. The accessory prosthesis can be deployed ina prescribed lumen prior to the deployment of the primary prosthesis andthe primary prosthesis can be deployed within it. The function of theaccessory prosthesis is to constrain the primary prosthesis at a reducedsize, yet allow diametrical adjustment as necessary.

In another embodiment, a prosthesis has a drug eluting lattice. Thelattice has at least one layer with a therapeutic agent that is disposedin between two nonpermeable layers. The therapeutic agent is sealedwithin the lattice between the two nonpermeable layers. The lattice alsodefines a plurality of openings and the therapeutic agent is sealedwithin the lattice at the inner walls of the lattice openings. As theprosthesis experiences a distensive force, the nonpermeable layersexpand, for instance, radially into an enlarged diametrical dimension,while the inner walls of the openings fail, break, crack or tear toallow the therapeutic agent to be released.

In another embodiment, a prosthesis is provided that is configured tohave pulsatile compliance. The prosthesis has a stent (i.e. aself-expanding stent), and can have a distal end and/or proximal endflared such that a diameter at an end of the stent is greater than adiameter defined in the center portion of the stent. The prosthesisfurther has a lattice defining a plurality of openings. These twocomponents of the prosthesis have large differences in mechanicalproperties. The lattice can be very elastic or flexible, and the stentis typically very stiff in comparison. Thus, the combination produces anelastic response within the physiological pressure range of a naturalvessel such as a blood vessel including for example a diseased bloodvessel. In an embodiment, the combination can produce a non-linearelastic response within the physiological pressure range of a naturalvessel. This characteristic of pulsatile expansion and contraction ofhost vessels requires fine mechanical compliance of the prosthesis,i.e., a close mimicking by the prosthetic device of the mechanics andtiming of the natural vessel distending and reshaping under change inblood pressure. An elastomeric lattice covering on the outer surface ofa stent embodiment provides an elastic constraining force to the stent(i.e. inward force) while the stent can provide an expansion force (i.e.outward force). This can be beneficial in avoiding draping of thelattice covering into the luminal space of the stent while it mayadditionally provide pulsatile compliance.

In another embodiment, a lattice includes a generally tubular membercontaining a plurality of openings and a luminal (inner) and exterior(outer) surface. The openings may each have a size of less than about2.0 mm, 1.0 mm, or even less than 0.5 mm. The generally tubular membercomprises a composite material that has an expanded fluoropolymermembrane and preferably an elastomer. The fluoropolymer may be expandedpolytetrafluoroethylene. In exemplary embodiments, the expandedfluoropolymer membrane includes serpentine fibrils. In at least oneexemplary embodiment, the expanded fluoropolymer membrane may include aplurality of serpentine fibrils.

An embodiment of an endovascular prosthesis can comprise a generallytubular lattice comprising at least two circumferential segments thatare oriented at an angle of between about 45 degrees and about 90degrees with respect to the longitudinal axis of the generally tubularlattice; wherein the generally tubular lattice is adapted to expandradially into an enlarged first diametrical dimension and at least onecircumferential segment of the lattice being resistant to furtherexpansion, and wherein the generally tubular lattice can be adjusted toa further enlarged second diametrical dimension when distensive force isapplied thereto and the circumferential segment resistant to furtherexpansion is plastically deformed or broken. The lattice can furthercomprise at least two longitudinal segments that are substantiallyparallel to the axis of the generally tubular lattice and wherein saidat least two longitudinal segments and said at least two circumferentialsegments define a plurality of openings.

An alternative embodiment of an endovascular prosthesis comprises alattice defining a plurality of openings; the lattice comprising (ii) atleast two circumferential segments that are oriented at an angle ofbetween about 45 degrees and about 90 degrees with respect to thelongitudinal axis of the prosthesis; wherein at least onecircumferential segment has excess length when the prosthesis expandsradially into an enlarged first diametrical dimension and at least onecircumferential segment of the lattice being resistant to furtherexpansion.

An embodiment of an endovascular prosthesis can comprise a multi-layerlattice resistant to dilation and creep; each layer of the latticedefines a plurality of openings wherein when the prosthesis expandsradially into an enlarged first diametrical dimension and at least onelayer of the lattice being resistant to further expansion, and whereinthe prosthesis can be adjusted to a further enlarged second diametricaldimension when distensive force is applied thereto and the layerresistant to further expansion is compromised.

Another embodiment of an endovascular prosthesis comprises a latticedefining a plurality of openings and having a generally tubular form;the lattice comprising (i) at least two longitudinal segments that aresubstantially parallel to a longitudinal axis of the lattice, and (ii)at least two circumferential segments that are oriented at an angle withrespect to the longitudinal axis; wherein at least one circumferentialor longitudinal segment has an excess length when the lattice expandsradially into an enlarged first diametrical dimension or longitudinallyinto an enlarged first linear dimension and at least one circumferentialor longitudinal segment of the lattice being resistant to furtherexpansion.

An embodiment of an endovascular prosthesis having a therapeutic latticereservoir comprises a lattice having at least two layers nonpermeable totherapeutic agents; and a reservoir layer disposed there betweencomprising one or more therapeutic agents; the lattice defines aplurality of openings having an inner wall and the therapeutic agent issealed within the reservoir layer at the inner wall of the openings;wherein as the prosthesis is adjusted to an enlarged diametricaldimension by a distensive force applied thereto, the inner wall of theopenings is adapted to be resistant to dilation allowing the therapeuticagent to be released.

An embodiment of an endovascular prosthesis with pulsatile compliancecomprises a stent having one or more ends; and a lattice defining aplurality of openings covering the stent; wherein a combination of thestent and the lattice produces an elastic response within aphysiological pressure range of a diseased blood vessel.

Another embodiment of a multi-layer lattice endovascular prosthesiscomprises a multi-layer lattice resistant to physiological pressures;each layer of the lattice defines a plurality of openings wherein whenthe prosthesis expands radially into an enlarged first diametricaldimension and at least one layer of the lattice being resistant tofurther expansion, and wherein the prosthesis can be adjusted to afurther enlarged second diametrical dimension when distensive force isapplied thereto and the layer resistant to further expansion iscompromised.

An embodiment of a lattice comprises a generally tubular member having aplurality of openings therein and a luminal surface and an exteriorsurface, wherein said member comprises a composite material including aleast one fluoropolymer membrane and an elastomer, and wherein saidfluoropolymer membrane includes serpentine fibrils.

The devices described herein have various uses. An exemplary use is in amethod of treating stenosis in a vessel. For example, the device is astent with a lattice having an insertion configuration with a reducedprofile and a deployed configuration with an enlarged profile greaterthan the insertion profile. This stent is inserted into the vasculatureof the patient. The stent is then positioned and deployed within thevessel.

Numerous variations and modifications of these exemplary prostheses andmethods of using them are contemplated. Additional features andadvantages of the invention will be set forth in the description or canbe learned by practice of the invention. These features and otheradvantages of the invention will be realized and attained by thestructure particularly pointed out in the written description and claimshereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory, andare intended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the invention, and are incorporated in and constitute apart of this specification, illustrate embodiments of the invention, andtogether with the description serve to explain the principles of theinvention.

In the drawings:

FIG. 1A is a plan view of a stent with a square-shaped lattice covering;

FIG. 1B is a close-up view of the stent illustrated in FIG. 1A;

FIG. 1C is a plan view of a stent with a diamond-shaped latticecovering;

FIG. 2A is a full view of a stent with a square-shaped lattice covering;

FIG. 2B is a close-up view of a stent at one of its ends with a squareshape lattice;

FIG. 2C is a close-up view of a stent at one of its ends with a diamondshape lattice;

FIG. 3A is a partial close-up view of a lattice prior to amicro-catheter advancing through a lattice opening;

FIG. 3B is a partial close-up view of a lattice as a micro-catheter isadvanced through a lattice opening;

FIG. 3C is a partial close-up view of a lattice after a micro-catheteris advanced through a lattice opening;

FIG. 4A is a partial close-up of a lattice;

FIG. 4B is a partial close-up of a lattice;

FIG. 4C is a partial close-up of the lattice of FIG. 4B applied to thelattice of 4A;

FIG. 4D is a partial close-up of the lattice openings in the lattice ofFIG. 4C;

FIGS. 5A-5C illustrate a partial close-up of a lattice withcircumferential segments of varying length during radial expansion;

FIGS. 6A-6C illustrate a partial close-up of a lattice with longitudinalsegments of varying length during longitudinal expansion;

FIGS. 7A-7C illustrate a partial close-up of each layer within amulti-layer lattice;

FIG. 7D is a partial close-up of a multi-layer lattice;

FIG. 8A is a plot of a diameter of the lattice that is configured toexpand in a sloped manner as a function of the distensive pressure.

FIG. 8B is a plot of a diameter of the lattice that is configured toexpand in a stepped manner as a function of the distensive pressure.

FIG. 9A is a partial close-up of a drug-eluting lattice;

FIG. 9B is a partial close-up of a drug-eluting lattice duringradial/longitudinal expansion;

FIG. 10 illustrate preparation and deployment steps of a drug-elutinglattice;

FIG. 11A is an accessory lattice;

FIGS. 11B-11D illustrate the deployment steps of an accessory lattice;

FIG. 12 illustrate the preparation and deployment of a prosthesis withpulsatile compliance;

FIG. 13 is a prosthesis having a constrained mid-section by a latticestructure;

FIG. 14 is a schematic illustration of an exemplary, idealizedserpentine fibril; and

FIG. 15 is a scanning electron micrograph of the surface of anelastomeric composite material with the copolymer removed.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the invention belongs. In the drawings, the thicknessof the lines, layers, and regions may be exaggerated for clarity. Likenumbers found throughout the figures denote like elements.

A prosthesis is a device adapted to be inserted into a body and thendeployed within the body such as within the carotid artery. Theprosthesis has a stent with a framework of struts or relatively rigidsections. Alternatively, the prosthesis has a graft with, for example, aflexible, cylindrical tubing supported by a plurality of circumferentialring-like scaffold elements. In yet another alternative, the prosthesishas a stent and a graft to form a stent-graft. Examples of such devicesare described in U.S. Pat. No. 6,361,637 to Martin et al. and U.S.Patent Publication 20070198077 to Cully, et al., the entire disclosuresof which are incorporated herein by reference. Most generally,prostheses assist in structurally supporting the host vessel lumen,maintaining patency through the vessel, passageway or opening, repairingvessels having an intimal flap or dissection, or isolating sections of ahost vessel lumen, such as aneurysms. In another embodiment, saidprosthesis are vascular grafts, e.g. GORE-TEX® Vascular Grafts, whichare used, inter alia, to create a conduit for repeated blood accessduring hemodialysis or as conduits between vessels. According to oneembodiment of the invention, any of the prosthesis mentioned above canbe customized to fit a particular anatomy, including adjusting itslength and inside diameters. In another embodiment, said prosthesis canalso be tapered along all or a portion of its length so that the insidediameter changes along the length.

Coverings can be provided for a stent, a graft, or a stent-graft.Alternatively, coverings can be used independently. The use of coveringsin combination with the stent, the graft, or the stent-graft can help,for example, to minimize or at least reduce the risk of introduction ofemboli into a bloodstream, resist tissue encroachment into the lumendefined by the stent, reduce pressure on a weakened part of a bloodvessel to reduce the risk of vessel rupture, and/or to create a conduitfor attaching at least two vessels. Coverings can be made fromcontinuous materials with no holes visible without magnification.

Various coverings can be provided independently or on the interior orexterior surfaces of the stent, the graft, the stent-graft, or both. Aprosthesis embodiment can have a covering attached to the luminal(interior) or exterior surface of the stent, the graft, or thestent-graft. The covered prosthesis can be used to isolate cells,aneurysms, vessel wall defects, and the like. Suitable coveringmaterials include bioabsorbable polymer (such as polylactic acid,poly(trimethylene carbonate) or PGA/TMC), fluoropolymer (such asfluorinated ethylene propylene or FEP, polytetrafluoroethylene or PTFEand expanded fluoropolymer, such as expanded polytetrafluoroethylene orePTFE), fluoroelastomer (for example, TFE/PMVE copolymers), polyester(such as polyethylene terephthalate or PET), polyethylene,polypropylene, polyurethane, metal mesh (such as a woven or cut nitinolsheet) silicone, etc.

The covering material can form a lattice having a plurality of openings.In an embodiment, the covering lattice material having a plurality ofopenings is attached to one or more surfaces of a stent, graft, or stentgraft. In such an embodiment, the covering lattice material canpartially cover one or more surfaces of the stent, graft, or stentgraft.

A lattice covering can have various uses. The lattice covering can beattached to one surface or multiple surfaces of a stent, graft, or stentgraft. For example, a lattice covered stent can provide plaquestabilization and scaffolding, while simultaneously allowing perfusionof blood from the inner lumen of the stent if the openings are sizedappropriately. This can be beneficial, for example, to perfuse sidebranch blood vessels. Alternatively, the relatively small latticeopenings can be provided (for example about 40 or 50 μm) to relievepressure from weakened portions of a blood vessel (for example, to treata cerebral aneurysm). The relatively small lattice openings also can beuseful for preventing encroachment of tissue from the patient into theinner lumen of the stent (for example, when the stent is placed nearcancerous tissue), while still permitting side branch perfusion.

FIGS. 1A and 1B illustrate two kinds of coverings, which can be termedto be lattices 200, which are attached to structures, which can betermed to be stents 100. These lattices are unitary structures. A seriesof interconnected, continuous segments define one or more patterns ofopenings in the lattice. The width of the lattice segments rangesbetween about 0.02 mm and about 0.2 mm, between about 0.02 mm and about0.1 mm, or about 0.05 mm. The thickness of the lattice segments rangesbetween about 0.02 mm and about 0.2 mm, between about 0.02 mm and about0.1 mm, or about 0.05 mm. The lattice opening size is the diameter ofthe largest inscribed circle, and ranges between about 40 μm and about 1mm, between about 50 μm and about 800 μm, between about 100 μm and about750 μm, or between about 200 μm and about 500 μm. The lattice openingsize can be the size of the smallest kerf width of a laser. A latticeopening for use in an application such as aneurysm exclusion can bebetween about 10 μm and about 40 μm, between about 12 μm and about 30μm, or between about 15 μm and about 20 μm.

The lattice openings can be arranged in various regular and irregularpatterns to provide diametrically stable functionality. The openings canhave various shapes, such as triangles, squares, diamonds,parallelograms, hexagons, circles, or any other geometric shape, orcombinations of shapes. FIGS. 1A and 1C show illustrative square anddiamond-shaped openings, respectively.

The square-shaped lattice of FIGS. 1A and 1B have a series of continuouslongitudinal segments (204) that extend in a direction that issubstantially parallel to a longitudinal axis of the prosthesis, and aseries of continuous circumferential segments (201) that extend in adirection that is at an angle approximately transverse to thelongitudinal axis of the prosthesis. In FIG. 1B, the square-shapedopenings have four equal or substantially equal sides and its interiorangles are all at or approximately right angles (90°).

The arrangement of the square-shaped lattice of FIG. 1B can providelongitudinal segments with substantially constant length in an insertionor constrained configuration (when the prosthesis, such as a stent, hasa reduced profile), and in a deployed configuration (when theprosthesis, such as a stent, has an enlarged profile greater than theinsertion profile). For example, as compared with overall length oflongitudinal lattice segments in the deployed configuration, thelongitudinal segments of the lattice can have lengths ±5% in theinsertion configuration, ±4% in the insertion configuration or ±2% inthe insertion configuration.

Alternatively, the lattice covering can have parallelogram-shapedopenings. Continuous longitudinal segments extend in a direction that issubstantially parallel to the longitudinal axis of the prosthesis, suchas a stent. Continuous circumferential segments extend at an angle withrespect to the longitudinal axis that is greater than 0° and less thanabout 90° with respect to the longitudinal axis. For example, thecircumferential segments can be oriented at an angle of about 45° withrespect to the longitudinal axis. In an embodiment, aparallelogram-shaped lattice can be positioned with respect to a stentso that one or more of the longitudinal segments extend along the lengthof the closed cell connectors.

Further, the lattice covering can have diamond-shaped openings as shownin FIG. 1C. Two sets of continuous circumferential segments extend atdifferent angles with respect to the longitudinal axis of theprosthesis. For example, a first set of the circumferential segments isoriented at an angle of about 45° with respect to the longitudinal axis,while a second set of the circumferential segments is oriented at anangle of about −45° and about −90° with respect to the longitudinalaxis. In the lattice depicted in FIG. 1C, there are no longitudinalsegments.

Yet still more lattice opening shapes can be obtained, such a triangles,or trapezoids, with additional lattice segments. For example, thelattice can have two sets of circumferential segments, as well aslongitudinal segments. One set of the circumferential segments can beoriented at an angle of between about 45° and about 90° with respect tothe longitudinal axis, while a second set of the circumferentialsegments can be oriented at an angle of between about −45° and about−90° with respect to the longitudinal axis.

When the lattice is provided as a covering for a stent, longitudinaland/or circumferential lattice segments can be positioned to extendalong one or more stent struts. For example, in FIG. 2B, longitudinalsegments of the square-shaped openings extend along one of the closedcell connectors of the circumferential member, and are longitudinallyaligned with it. The number of longitudinal segments of the latticecovering can be the same as or greater than the number of the closedcell connectors in each of the circumferential members. One, some, orall of the longitudinal members can be joined with the closed cellconnectors. Similarly, other shaped openings of the lattice can bealigned so that one or more sides extend along the length of one or moreconnector struts within the stent.

The number of attachments between a stent and the lattice covering canbe varied depending on various factors, such as the size of the stentopenings, the size of the lattice openings, and the orientation of thelattice with respect to the stent. In FIGS. 2B and 2C, the closed cellsof the stent have a larger dimension along the longitudinal axis, and ashorter dimension transverse to the longitudinal axis. In FIG. 2B, thesquare-shaped lattice covering is oriented with fewer lattice openingsacross the larger dimension of the closed cell, and an equal or fewerlattice openings across the smaller dimension of the closed cell. InFIG. 2C, the diamond-shaped lattice covering is oriented with morelattice openings across the smaller dimension of the closed cell than inFIG. 2B.

A substantially uniform lattice opening pattern is shown in FIGS. 1A-1C.In those lattices, the size and shape of the openings is substantiallyuniform throughout. However, the lattice opening pattern also can beirregular. Lattice openings can be provided in one portion and not inthe balance of the lattice. For example, a first arc of the lattice canhave openings along the entire length of the lattice while a second arcopposite of the first arc is substantially without openings.Alternatively, the lattice openings can be provided in along a spiralwith respect to the longitudinal axis. Further still, the lattice canhave a perfusion region within which the openings are provided and anexcluding region devoid of openings, thus, configured to alloworientation of the perfusion region to be determined endovascularly.

Alternatively, the lattice openings can have several patterns. Theopenings of similar size and shape can be grouped together to have atleast two sets of openings with each set having a predetermined size andshape, or uniformly distributed throughout the lattice. For example,lattice openings corresponding to the circumferential members can besquare-shaped as depicted in FIG. 1A, while the lattice openingscorresponding to the helical element can be diamond-shaped as depictedin FIG. 1C.

Alternatively, the lattice can have three sets of openings distributedalong the length of the lattice, one at the proximal end, one at thedistal end and one in-between. The openings of the proximal set, forexample, can have diamond-shaped openings with a nominal diameter ofabout 300 μm as measured by the largest inscribed circle. The openingsof the distal set, for example, can also have diamond-shaped openingsbut with a nominal diameter of about 500 μm as measured by the largestinscribed circle. On the other hand, the openings of the central set,those that span between the proximal and distal sets, can havesquared-shaped openings with a nominal diameter of about 100 μm asmeasured by the largest inscribed circle. Other permutations, sets, andgroupings are also envisioned. For example, in addition to the square ordiamond-shaped lattice openings, one or more large oval openings adaptedto allow for side branch perfusion can be provided.

The lattice can be produced by laser cutting, such as a CO₂ laser, froma longitudinally wrapped tube of, for example, six layers ofbiaxially-oriented film made from one suitable covering material or froma combination of suitable covering materials to produce a unitarystructure, not woven. Such a lattice could have a nominal thicknessbetween about 10 μm and about 250 μm, between about 20 μm and about 60μm, or between about 35 μm and about 50 μm. Other films can be usedtogether with the biaxially-oriented films or in place of them to formthe lattice. For example, uniaxially-oriented or multiaxially-orientedfilms can be used. These films can be wrapped longitudinally asdescribed above, or can be wrapped in other configurations. For example,the films can be helically wound to form the tubular structure. Othermethods of lattice preparation are also envisioned in accordance withthe procedures described in U.S. Pat. Pub. No. 2008/0119943 to Armstronget al., or U.S. Pat. No. 7,306,729 to Bacino et al., the entiredisclosures of which are incorporated herein by reference.Alternatively, a lattice can also be formed from a fiber by techniquessuch a knitting, weaving, or crocheting.

Conformability of the stent with and without the lattice can be measuredaccording various known test methods. For example, ISO 25539-2 (2008)describes one protocol for assessing the ability of medical devices toconform to vessel walls and is incorporated in and constitutes a part ofthis specification. Most generally, the test method measures thesmallest radius of curvature that a stent can withstand without kinking.A more conformable stent will have greater ability to conform to bendshaving a smaller radius of curvature without kinking, and a lessconformable stent will have a lesser ability to conform to such bendswithout kinking.

Flexibility of the stent with and without the lattice can be assessed bya three-point bend test on deployed stents. One method for such testingis set forth in ASTM F2606-08, the entire disclosure of which isincorporated herein by reference. Most generally, after the stent isplaced into a specific three-point bend fixture, the amount of forcerequired to bend the stent is measured. The resulting load-deflectioncurves can be used to assess flexibility of stents. A more flexiblestent will have greater ability to bend at lower forces, and a lessflexible stent will have a lesser ability to bend at lower forces.

The stent, stent graft, and/or vascular graft and the lattice can besized to be the same or different. For instance, the lattice covering astent as shown in FIGS. 1A, 1C, 2A and 2B does not notably constrain thestent. For example, the stent has an outer diameter of about 8 mm, andthe lattice has an inner diameter of about 8 mm.

Alternatively, however, the lattice can resist full expansion of thestent, e.g. a self-expanding stent, depending upon lattice geometry andmaterial chosen. This can be achieved by over-sizing the stent withrespect to the lattice covering. The stent can have an outer diameterthat is oversized with respect to the lattice covering in an amount ofabout 10% to about 100%, between about 20% and about 70%, or between 30%and about 50%. For example, the self-expanding stent can have an outerdiameter of about 10 mm, and the lattice can have an inner diameter ofabout 8 mm. An effect of oversizing the stent as compared to the lattice(in this example to about 20%) is to provide a final self-expandingdevice that resists forces tending to collapse the deployed stent. Theamount of force needed to reduce the diameter of the deployed stent ishigher when an oversized self-expanding stent is used as compared withthe same stent that is not oversized.

In addition to oversizing the stent as compared with the lattice, thelattice can be made from a rapidly recovering distensible material thatis capable of being stretched and then recovering. A rapidly recoveringdistensible material for the lattice can be made according to variousknown techniques, such as in accordance with the procedures described inU.S. Pat. Nos. 4,877,661 and 5,026,513 to House et al., the entiredisclosures of which are incorporated herein by reference. The latticemade from rapidly recovering distensible material can have a rapidrecovery of greater than about 5.5%, greater than about 15%, or greaterthan about 30%. For example, the stent can be sized to have an outerdiameter of about 8 mm, and the rapidly recovering distensible latticecan be sized to have an inner diameter of about 6 mm. Although the aboveembodiments describes a stent and lattice, other prosthesis can be usedin combination with a lattice, including, but not limited to stent-graftand vascular grafts

The lattice can have longitudinal and/or circumferential latticesegments of varying length that are configured to provide resistance todilation and creep and expand in a sloped or a stepped manner. The terms“dilation” and “creep” as used herein are meant to denote chronictime-dependent radial or longitudinal expansion of the prosthesis inresponse to physiological or stent-induced stress on the prosthesis. Thesegments in the lattice can be configured to plastically deform orrupture depending on the prescribed diametrical dimension and theapplied pressure. The lattice covering 200 shown in FIG. 5A is notconstrained and expands radially into an enlarged first diametricaldimension d1. A circumferential segment 201 of the lattice 200 is underload and resistant to further expansion, whereas circumferentialsegments 202 and 203 are tension-free. The circumferential segment 202is constructed with excess length (shown as a hump) that allows thecircumferential segment 202 to expand to an enlarged second diametricaldimension d2. The circumferential segment 203 is also constructed withexcess length (shown as two humps) that allows the circumferentialsegment 203 to expand to an enlarged third diametrical dimension d3. Thelattice 200 can be adjusted to a further enlarged second diametricaldimension d2 as shown in FIG. 5B, when distensive force is applied tothe lattice 200. When the distensive force reaches a prescribedpressure, the circumferential segment 201 ruptures. Alternatively,instead of rupturing, the circumferential segment 201 can be plasticallydeformed. A balloon catheter can be used to exert the distensive force.Once the lattice 200 expands radially into an enlarged seconddiametrical dimension d2, the circumferential segment 202 assumes theload. However, the circumferential segment 202 is resistant to furtherexpansion, whereas circumferential segment 203 is still relaxed. Thelattice 200 can be adjusted to a further enlarged third diametricaldimension d3 as shown in FIG. 5C, when distensive force is applied tothe lattice 200. When the distensive force reaches a prescribedpressure, the circumferential segment 202 ruptures and thecircumferential segment 203 assumes the load. Alternatively, thecircumferential segment 201 can be plastically deformed instead ofrupturing. Although, only three segments of varying length are shown inFIGS. 5A-5C, the number can range from 2 to 1000. The width of thesegments can also vary depending on the pressure at which the segmentsare desired to be plastically deformed or ruptured.

FIGS. 8A and 8B show a relationship between the pressure applied duringexpansion and the diameter of the lattice. As depicted in FIG. 8A, ifthe segments are plastically deformed, the lattice expands in a slopedmanner. For example, a lattice can have a diameter of 8 mm and it holdssuch diameter until the pressure reaches about 6 atm. Once 6 atm isexceeded, the lattice begins to plastically deform. Continuedapplication of pressure results in continued diametrical increase untilthe lattice ruptures or, as shown in FIG. 8A, it reaches a “hard-stop”built into the lattice, e.g., diameter of 12 mm. As depicted in FIG. 8B,if the segment ruptures, the lattice expands in a stepped manner, thusallowing for discreet diametrical steps. For example, a lattice can havea diameter of 8 mm and it holds such a diameter until the pressurereaches about 6 atm. Once 6 atm is exceeded, certain segments that areresistant to further expansion break and the lattice instantly expandsto a diameter of about 10 mm. Again, the lattice holds such a diameteruntil the pressure reaches about 8 atm. Once 8 atm is exceeded, certainsegments that are resistant to further expansion break and the latticeinstantly expands to a diameter of about 12 mm.

In addition to expanding the whole prosthesis, only a portion can beradially or longitudinally expended that can provide a high degree ofaccuracy during implementation. Any portion of the prosthesis can beexpanded to create any shape, such as a dog bone shape, an hour glassshape, or a taper. For example, the proximal and distal ends of theprosthesis can be expanded to retain a dog bone shape shown in FIG. 13that is resistant to dilation and creep. The prosthesis can be taperedalong all or a portion of its length so that the diameter changes alongthe length. A tapered length section may be located closer to either endof the prosthesis, or the taper may exist as a uniform, gradual taperextending between the prosthesis ends.

A lattice covering can allow an adjustment in its length. The lattice200 shown in FIG. 6A has longitudinal segments of varying length thatare substantially parallel to a longitudinal axis of the prosthesis. Thelattice 200 shown in FIG. 6A is not constrained and expandslongitudinally into an enlarged first linear dimension 11. Alongitudinal segment 204 of the lattice 200 is under load and resistantto further expansion, whereas longitudinal segments 205 and 206 are notunder load. The lattice 200 can be adjusted to a further enlarged secondlinear dimension 12 as shown in FIG. 6B, when a force is applied to thelattice 200. When the force reaches a prescribed pressure, thelongitudinal segment 204 ruptures and the lattice 200 expands to afurther enlarged second linear dimension 12. Alternatively, instead ofrupturing, the longitudinal segment 204 can be plastically deformed. Theprocess can be once again repeated as the linear expansion continuesinto the third enlarged linear dimension 13 shown in FIG. 6C.

In addition to providing the lattice that can have lattice segments ofvarying length configured to expand in a sloped or a stepped manner, thelattice can also have a stent or stent frame attached at either end ofthe lattice, or the lattice can be interposed between two stents orstent frames. By incorporating the lattice between two stent frames,such device can function as an “accessory” prosthesis that can constrainthe primary prosthesis deployed within it, yet allow diametricaladjustment as deemed necessary. Herein, the term “primary prosthesis” isdefined as the main device chosen as therapy for the treatment site. Anaccessory prosthesis 300 is shown in FIG. 11A. The prosthesis 300 has alattice 200 interposed between two stent frames 150 at its distal andproximal ends. The accessory prosthesis can be deployed in a prescribedlumen prior to the deployment of the primary prosthesis as depicted inFIG. 11B. A delivery system of such a device may be by means ofmechanical or hydraulic distension or a sheath-type delivery system ifthe device is configured to self-expand. Deployment of the accessoryprosthesis can be immediately prior to the deployment of the primaryprosthesis or as a staged procedure. In the staged procedure, theaccessory stent can be deployed one day, two days, one week, two weeksor any other prescribed time before the deployment of the primaryprosthesis. If deployed immediately prior to the deployment of theprimary prosthesis, both the accessory prosthesis and the primaryprosthesis can be provided on the same catheter, yet spaced axiallyapart. Once the accessory prosthesis lattice device is deployed, thecatheter system can then be advanced and the primary prosthesis deployedwithin it. Such a setup can reduce procedural time and radiationexposure by eliminating catheter exchanges while also minimizingintroductory profile. As shown in FIG. 11C, a stent 100 is deployedwithin the accessory prosthesis 300. If necessary, the accessoryprosthesis 300 can be radially expanded with the stent 100 as shown inFIG. 11D. The open structure of lattice 200 allows intended hostbiological response and interaction with the abluminal surface of theprimary prosthesis. For instance, if the abluminal surface of theprimary prosthesis is coated with a drug or has an engineeredmicrostructure to accelerate cellular ingrowth, the lattice willminimally inhibit these functions.

A lattice covering can stretch or deform when advancing a catheter orother tool from a deployment system through its sidewall to allowcrossing for deployment of a side branch device or other device. Thelattice can substantially return to its structure, size and shape oncethe side branch or additional device is deployed and that deploymentsystem removed from the lattice. FIG. 3A is a partial view of a latticecovering prior to micro-catheter advancement. FIG. 3B is a partial viewof the lattice with a micro-catheter advancing through one of thelattice openings and showing the opening deforming to take the shape ofthe outer diameter of the micro-catheter. FIG. 3C is a partial view ofthe same lattice in FIG. 3B after the micro-catheter is removed andshows that the lattice opening has substantially returned to itsoriginal size and shape. In another method, a balloon catheter isadvanced through one of the lattice openings instead of amicro-catheter. The balloon is deployed to size the opening forplacement of a side branch stent, graft or stent graft. In sizing, thelattice opening can deform to take the shape of the outer diameter ofthe balloon. Once the side branch stent, graft or stent graft is placedinto the balloon sized opening of the lattice, the lattice openingconforms to the shape of the side branch stent, graft or stent graft.

A lattice covering can be formed from longitudinal strips of any of thecovering materials described herein including by bonding or weaving intoa basket weave, mesh, or lattice pattern that define a plurality ofopenings.

Optionally, a stent, graft, or stent-graft can be covered with multiplelayers of coverings. A lattice can be formed by two or more layers oflattice coverings. Two or more layers can be bonded together withopenings aligned or offset. One or more of the layers can have elasticproperties. As used herein, the term “elastic” refers to the property ofa material to be elongated upon the application of a force and thatreturns to its approximate original dimensions upon the release of theforce due to the retraction force of the material. Two lattice coveringsas shown in FIGS. 4A and 4B can be layered such that the openings areoffset or staggered as shown in FIG. 4C. The resulting open area, asshown in FIG. 4D, may provide smaller trans-mural porosity than may beachieved by utilizing a single lattice covering.

One or more of the layers within a lattice can have same or differentexpanded diameter. The lattice having multiple layers with differentexpanded diameters can be configured to expand in a stepped rather thansloped manner while providing resistance to dilation and creep. A leastone layer in such a lattice has a fully expanded diametrical dimensiondiameter that is greater than at least one other layer in the samelattice. When not constrained the lattice can expand radially into anenlarged diametrical dimension that is lesser of two. At this level ofexpansion, at least one layer is under tension and is resistant tofurther expansion. The lattice, however, can be adjusted to a furtherenlarged second diametrical dimension when distensive force is appliedto the lattice and at a prescribed pressure, the layer that is resistantto further expansion fails. For example, the linking segments within thelayer are plastically deformed or ruptured. Once the lattice expandsradially into an enlarged second diametrical dimension, at least oneother layer assumes the load and is resistant to further expansion.

As depicted in FIGS. 7A-7D, the lattice 200 has three layers 200 a, 200b, and 200 c. Each layer has at least two longitudinal segments (204,205, 206) and at least two circumferential segments (201, 202, and 203).Each circumferential segment 201 of layer 200 a has a fully expandeddimension x. Each circumferential segment 202 of layer 200 b is built atdimension x but has a fully expanded dimension y. Each circumferentialsegment 203 of layer 200 c is built at dimension x but has a fullyexpanded dimension z. The relationship between the illustrateddimensions is z>y>x. When not constrained the lattice 200 can expandradially into an enlarged diametrical dimension x. At this level ofexpansion, layer 200 a is under tension and is resistant to furtherexpansion. The lattice 200 can be adjusted to a further enlarged seconddiametrical dimension y when distensive force is applied to the lattice200. When the prescribed pressure is exceeded, layer 200 a of thelattice 200 fails, i.e., ruptures or plastically deforms. For example,the circumferential segments 201 within layer 200 a are plasticallydeformed or ruptured. The lattice 200 expands radially into an enlargedsecond diametrical dimension y. Layer 200 b of the lattice 200 assumesthe load and is resistant to further expansion. Once again, the lattice200 can be adjusted to a further enlarged third diametrical dimension zwhen distensive force is applied to the lattice. When the prescribedpressure is exceeded, layer 200 b of the lattice 200 fails. Lattice 200expands radially into an enlarged third diametrical dimension z. Oncethe lattice 200 expands radially into an enlarged third diametricaldimension z, layer 200 c of the lattice 200 assumes the load and isresistant to further expansion.

Alternatively, the multi-layer lattice can be configured to radiallyand/or longitudinally expand in a partially stepped and a partiallysloped manner. With reference to FIG. 7D, for example, the segments inlayer 200 a are broken, the segments in layer 200 b are plasticallydeformed and the segments in layer 200 c are broken.

The prosthesis is provided that is configured to have pulsatilecompliance. The characteristic of pulsatile expansion and contraction ofvessels requires fine mechanical compliance of the prosthesis, i.e., aclose mimicking by the prosthetic device of the mechanics and timing ofthe natural vessel distending and reshaping under change in bloodpressure. Such prosthesis has a stent. The stent can be flared at one ormore ends. For example, both ends of the stent can be flared. That is, adiameter at an end of the stent is greater than a diameter defined atthe center of the stent. The prosthesis further has a lattice defining aplurality of openings. These two components of the prosthesis have largedifferences in mechanical properties. The lattice is very flexible orelastic, and the stent is typically is very stiff in comparison. Thus,the combination produces a non-linear elastic response within thephysiological pressure range of a natural vessel. The lattice can bemade from a rapidly recovering distensible material and/or a materialwith elastic properties, for example a composite material, including atleast one fluoropolymer membrane and elastomer. FIG. 12 illustrates thecombination of a stent 100 with at least one end flared combined with alattice 200, which can be deployed in a vessel to produce a non-linearelastic response to physiological pressure between diameters d and d′.

A lattice can be imbibed with PVA (polyvinyl alcohol) or other materials(e.g., gold, platinum/iridium, or the like) to aid the physician duringimaging (e.g., ultrasound, fluoroscopy, MRI, or the like). A lattice canbe imbibed with one or more therapeutic agents. The term “imbibed orimbibing” as used herein is meant to describe any means for at leastpartially filling a portion of the pores of a porous material such asePTFE or the like. This can be done during manufacturing by, for exampleimbibing, or it can be done during catheter flushing which may imbibe orcoat one or more therapeutic agents into or onto the lattice. Imbibingor coating of a therapeutic agent can result in release of the agentover time. One skilled in the art can select suitable therapeutic agentsincluding without limitation: sirolimus, dexamethoasone, paclitaxel,phosphorylcholine, everolimus, or like agents. As used herein, atherapeutic agent can be a drug or other pharmaceutical product such asa non-genetic agents, genetic agents, cellular material, etc. Someexamples of suitable non-genetic therapeutic agents include but are notlimited to: anti-thrombogenic agents such as heparin, heparinderivatives, vascular cell growth promoters, growth factor inhibitors,paclitaxel, etc. Where an agent includes a genetic therapeutic agent,such a genetic agent may include but is not limited to: DNA, RNA andtheir respective derivatives and/or components: hedgehog proteins, etc.Where a therapeutic agent includes a cellular material, the cellularmaterial may include but is not limited to: cells of human origin and/ornon-human origin as well as their respective components and/orderivatives thereof. Where the therapeutic agent includes a polymeragent, the polymer agent may be apoly-styrene-polyisobutylene-polystyrene triblock copolymer (SIBS),polyethylene oxide, silicone rubber and/or any other suitable substrate.In at least one embodiment the polymer agent can be biodegradable suchas PLA, PLGA, etc. A therapeutic agent can also be a coating material asdescribed herein.

A lattice can be imbibed with one or more therapeutic agents that can bereleased during distension. As shown in FIGS. 9A and 10, this can bedone during manufacturing by preparing a multi-layer lattice 200 with areservoir layer 211 having a therapeutic agent. The reservoir layer 211is disposed between at least two layers 210, such as ePTFE, that arenonpermeable to the therapeutic agent. The openings 212 in the latticecan be produced by laser cutting, such as a CO₂ laser. During lasercutting, the polymer adhesive used in manufacture of a multi-layerlattice, such as FEP or TFE/PMVE, reflows and seals the inner walls ofthe openings 212, holding the therapeutic agent within the reservoirlayer 211. To avoid any negative thermal effect on the therapeutic agentduring manufacturing, the laser used for cutting openings in the latticeis substantially focused and the layers can be joined together bycompression and the polymer adhesive reflow at the inner walls of theopenings 212. As the prosthesis expands during deployment by means ofmechanical or hydraulic distension, the nonpermeable layers 210 expand,for instance, radially into an enlarged diametrical dimension. Even inexpanded state, the nonpermeable layers 210 typically do not allow therelease of the therapeutic agent. In contrast, the inner walls of theopenings 212 are compromised immediately upon expansion. As shown inFIGS. 9B and 10, the inner walls fail, break, crack or tear to allow thetherapeutic agent 211 a to be released. The cracks in the inner wallstypically develop across the entire lattice that helps to achieve a highrate of release throughout the lattice by providing a conduit throughwhich the therapeutic agent can easily and quickly diffuse from thereservoir layer.

A lattice can also be imbibed with an alginate. The alginate can beimbibed throughout the lattice or selectively to one or more portions ofthe lattice. The alginate can be cross-linked by delivering divalent ortrivalent cations (for example, calcium) though a catheter or theprosthesis delivery system to the prosthesis delivery site. Thecross-linked alginate portion of the lattice can be used to relievepressure from weakened portions of a blood vessel (for example, to treata cerebral aneurysm) or to occlude other openings or vessels adjacent tothe sidewall of the stent. A lattice can be imbibed with calcium. Analginate can be delivered to the calcium imbibed lattice through theprosthesis delivery system or by another catheter system to causecrosslinking on or in close proximity to the lattice. A stent with acalcium imbibed lattice can be placed over an aneurysm neck and then onecan introduce the alginate through the lattice and into the aneurysm.While flowing through the calcium imbibed lattice, the alginate canreact with the calcium to cause formation of a gel in the aneurysm sac.

In FIGS. 1A and 1B, the lattice is shown to be generally uniform.Alternatively, the lattice covering can be varied along its length. Forexample, the size of the openings, the orientation of the openings andtheir shapes need not be uniform throughout the lattice covering. Aportion of the lattice covering can have square-shaped openings andanother portion of the lattice covering can have diamond-shapedopenings.

These coverings can be joined to a stent, graft, or stent-graft over allor over only a portion of the device length. The coverings can be joinedintermittently. For example, a lattice covering can be joined only atthe ends of the stent, graft, or stent-graft, at the closed cellportions of the stent, or only at the closed cell connectors. Thecovering can be on the outside of the stent, graft, or stent-graft; itcan be on the inside of the stent, graft, or stent-graft; or it can beon both.

The attachment of the lattice covering to a stent, graft, or stent-graftcan be accomplished by mechanical means such as fiber, friction fit,braiding a lattice into the stent, graft, or stent-graft, or discretemechanical attachment points (clips, etc.). The covering also can beattached by a single longitudinal strip. These components also can bebonded together through heat treatment (such as, sintering of thematerials together) or through use of a wrap (for instance a tube, tape,or membrane) around the outside of the covering and stent, graft, orstent-graft (either continuous or discontinuous), that is adheredthrough either a thermoplastic or thermoset adhesive. The covering alsocan be attached to the stent, graft, or stent-graft by adhering the twotogether through use of a suitable adhesive. The covering can also beheld in place through friction or as an interference fit. The coveringcan be held down at one or both ends. Combinations of these methods alsocan be used. These methods and combinations of these methods can be usedto attach the stent and covering while under inert gas conditions ascommonly known in the art.

Among suitable biocompatible adhesives are thermoplastic adhesives suchas fluorinated ethylene propylene (FEP), polyurethane, cyanoacrylate,thermoplastic fluoropolymer, including flouroelastomers such as thosedisclosed in U.S. Pat. No. 7,049,380 [TFE/PMVE], etc. Thermosetadhesives are also useful, such as silicone including room temperaturevulcanizing (RN) silicone.

For example, where the covering is a PTFE lattice; fluorinated ethylenepropylene (FEP) can be used as an adhesive. Such a coating can beapplied by various methods including extrusion over the covering, powdercoating with powdered FEP that is subsequently melted to flow over thelattice surface, or running the covering through a bath of molten FEPoptionally followed by pulling the covering through a die to achieveuniformity of the coating. Alternatively, the stent can be provided witha coating of adhesive such as by powder coating with FEP in a continuousor discontinuous fashion, or through use of an FEP wrap (for instance atube, tape, or membrane). In an embodiment, FEP can attach the latticeto the external surface of a stent by covering all surfaces of thestent.

A covering can be provided that allows the stent, graft, or stent-graftto be embedded within the covering material, such as through use of asilicone or other elastomeric material.

Coverings can be coextensive with the length of the stent, graft, orstent-graft, as shown in FIGS. 1A-1C and 2A-2C, or they can be eitherlonger or shorter than the stent, graft, or stent-graft. Coverings canalso cover only a portion of the stent, or can cover separately two ormore portions of the stent. If multiple portions are covered, coveringscan also overlap on the stent, graft, or stent-graft. For instance, oneportion of the stent can be covered, while another portion remainsuncovered as described in U.S. Pat. No. 6,673,102 to Vonesh et al., theentire disclosure of which is incorporated herein by reference. In oneembodiment, the uncovered portion of the stent-graft in U.S. Pat. No.6,673,102 is constrained by a lattice, wherein said lattice coveredstent can be diametrically adjusted according to any one of the methodsdescribed above. Such a device allows for custom sizing of theprosthesis in order to adjust the prosthesis to a unique anatomy.

Additionally, the lattice covering and the stent, graft, or stent-graftor both can be provided with additional treatment or therapeutic agents,such as drugs, radiation, radiopaque markers or coatings, or otheragents to enhance visualization in-vivo. For example, various coatingscan be provided on all or some of the covering, the stent, graft, orstent-graft, or both. Suitable coating materials includefluoroelastomer, ceramic, silicone, polyethylene, carbon, gold, heparin,hydrogel, lubricious coatings, antibiotics, anticoagulant agents,anti-inflammatory agents, antimetabolic agents, antimicrobial agents,antimigratory agents, antiplatelet agents, antiproliferative agents,antisense agents, cytostatic agents, nitric oxide releasing agents,pro-endothelial agents, selective gene delivery vectors, super oxidedismutases, super oxide dismutases mimics, vasoactive agents, andcombinations thereof, such as, for example, actinomycin-D, ciclosporin,clobetasol, dexamethasone, estradiol, everolimus, heparin, paclitaxel,pimecrolimus, rapamycin, sirolimus, tacrolimus, and derivatives of thesecompounds. Coating materials can provide numerous benefits, includingprotecting the underlying stent material, providing a substrate fordelivery of drugs or other therapeutic substances, isolating the stentmaterial from interaction with surrounding cells, improving fluoroscopicvisualization. Coatings can be applied in any material-appropriatemanner, such as dip-coating, spray-coating, electro-deposit, or chemicalvapor deposition.

Such a prosthesis can be used to treat various body lumens, including,the aortoiliac, carotid, cerebral, coronary, hepatic, infrainguinal,mesenteric, renal, splenic, subclavian, and superior mesenteric arteriesand veins as well as other bodily conduits such as the common bile duct,pancreatic duct, urethra intestines and colon. Such a prosthesis'configuration allows it to conform to the native anatomy of bloodvessels or other body lumens, while also enhancing the stent's fatigueperformance and crush-resistance.

For example, a prosthesis as described herein can be used for treatingstenosis in a carotid artery of a patient. A prosthesis is providedhaving an insertion configuration with a reduced profile and a deployedconfiguration with an enlarged profile greater than the insertionprofile. For example, the prosthesis can have a nitinol stent which iscapable of self-expanding to the deployed configuration when aconstraint is removed. The prosthesis is inserted into the vasculatureof the patient. The prosthesis is then positioned and deployed withinthe patient's artery, for example, at a position where plaque has causeda narrowing of the artery.

The prosthesis can be implanted by a catheter delivery system orsurgically (e.g. implanting a vascular graft). If the prosthesis isimplanted by a catheter, the prosthesis can be radially compressed andplaced within a sheath (or any constraining device). The sheath can besubsequently mounted on a 3F to 25F introducer-sheath compatibledelivery system, depending on the prosthesis and/or the anatomy to whichsaid prosthesis will be delivered. To aid visualization during deliveryand deployment, one or more radiopaque markers can be integrated intothe delivery system. For example, one radiopaque marker, such as BaSO₄,can be placed into the polymer used for the distal tip of the catheter.Another radiopaque marker, such as a platinum/iridium band, can beincorporated into the sheath material to indicate progression of thesheath retraction during stent deployment. Additionally, two markers,such as gold, platinum, or tantalum, can be placed adjacent to theproximal and distal ends of the compressed stent to aid in positioning.

Exemplary deployment systems that can be used in conjunction with theprosthesis disclosed herein include U.S. Pat. Nos. 6,139,572; 6,352,561and 7,198,636 which are incorporated by reference herein.

It can be beneficial to use the disclosed coverings independently, onthe stent, on the graft, or on the stent-graft hybrid. For example, acovering can provide a scaffold to reduce the risk of introduction ofemboli being released into a bloodstream. A covering also can resisttissue encouragement into the lumen defined by the stent. Further, acovering can help to reduce pressure on a weakened part of a bloodvessel, which in turn can reduce the risk of vessel rupture.

For example, for carotid applications, the stent with a lattice (seeFIGS. 1A and 1B) can be useful for treating carotid stenosis. Thelattice covered stent has flexibility and can conform to the anatomy bydistending the stent and lattice to the desired size and shape of thevessel.

The method for doing so includes several steps. First, a prosthesisincluding a lattice and a stent is provided. Second, the prosthesis isinserted into the patient while the prosthesis is in an insertionconfiguration with a reduced profile. Third, the prosthesis is movedthrough the patient's vasculature and positioned with the portion of thecarotid artery to be treated. Fourth, the prosthesis is deployed so thatit assumes an enlarged profile greater than the insertion profile.Fifth, a distending pressure is applied to the stent and lattice todistend the stent to fit the anatomy of the vessel. Said distendingforce can be applied, for example, via a medical balloon.

In this method, the lattice and the stent are configured and positionedafter deployment so that the stent provides scaffolding necessary tohold the artery open and ensure adequate blood flow, while the latticein combination with the stent simultaneously provides the correct sizeand shape.

The lattice openings can further provide perfusion to a side branchvessel in this application when properly positioned. For example, alattice can have a perfusion region with openings and an excludingregion substantially without the openings. By determining theorientation of the perfusion region endovascularly, the lattice coveredstent can be positioned so that the perfusion region allows side branchperfusion. Orientation can be determined by fluoroscopic visualizationof one or more radiopaque markers incorporated within the lattice.

Also, a lattice covered stent can be used in conjunction with ballooncatheters and/or guidewires, for example, to provide perfusion to a sidebranch vessel. After initially deploying the lattice covered stent asabove, a balloon catheter can be endovascularly introduced into a one ofthe openings of the lattice, and expanded to permanently distend ordisrupt the lattice covering. This allows endovascular modification ofthe size and shape of at least that one opening. Again, this can help toprovide side branch perfusion among other uses.

In another embodiment, lattice coverings comprising fluoropolymermembranes that exhibit high elongation while substantially retaining thestrength properties of the fluoropolymer membrane are utilized to atleast partially cover the stent, graft, or stent-graft. As discussedabove, the coverings can be provided independently or on the interior orexterior surfaces of the stent, the graft, or the stent-graft. The term“elongation” or “elongated” as used herein is meant to denote theincrease in length in response to the application of a tensile force.Such membranes characteristically possess serpentine fibrils, such asthe idealized serpentine fibril exemplified in FIG. 14. As depictedgenerally in FIG. 14, a serpentine fibril curves or turns generally oneway in the direction of arrow 10 then generally another way in thedirection of arrow 20. It is to be understood that the amplitude and/orfrequency of the serpentine-like fibrils as exemplified in FIG. 1 mayvary. In one embodiment, the fluoropolymer membranes are expandablefluoropolymer membranes. Non-limiting examples of expandablefluoropolymers include, but are not limited to, expanded PTFE, expandedmodified PTFE, and expanded copolymers of PTFE. Patents have been filedon expandable blends of PTFE, expandable modified PTFE, and expandedcopolymers of PTFE, such as U.S. Pat. No. 5,708,044 to Branca; U.S. Pat.No. 6,541,589 to Baillie; U.S. Pat. No. 7,531,611 to Sabol at al.; U.S.patent application Ser. No. 11/906,877 to Ford; and U.S. patentapplication Ser. No. 12/410,050 to Xu et al.

The high elongation is enabled by forming relatively straight fibrilsinto serpentine fibrils that substantially straighten upon theapplication of a force in a direction opposite to the compresseddirection. The creation of the serpentine fibrils can be achievedthrough a thermally-induced controlled retraction of the expandedpolytetrafluoroethylene (ePTFE), through wetting the article with asolvent, such as, but not limited to, isopropyl alcohol or Fluorinert®(a perfluorinated solvent commercially available from 3M, Inc., St.Paul, Minn.), or by a combination of these two techniques. As usedherein, the term “controlled retraction” refers to causing articles toshorten in length in at least one direction by the application of heat,by wetting with a solvent, or by any other suitable means orcombinations thereof in such a way as to inhibit folding, pleating, orwrinkling of the subsequent article visible to the naked eye.

The retraction of the article does not result in visible pleating,folding, or wrinkling of the ePTFE, unlike what occurs during mechanicalcompression. The retraction also can be applied to very thin membranes,unlike known methods. During the retraction process, the fibrils notonly become serpentine in shape but also may also increase in width.Upon retraction, the expanded fluoropolymer membrane possessesserpentine fibrils. These retracted membranes characteristically possessserpentine fibrils and are wrinkle free.

The precursor materials can be biaxially expanded ePTFE membranes. Inone embodiment, materials such as those made in accordance with thegeneral teachings of U.S. Pat. No. 7,306,729 to Bacino, et al. aresuitable precursor membranes, especially if small pore size articles aredesired. These membranes may possess a microstructure of substantiallyonly fibrils. In some exemplary embodiments, the membranes may possess amicrostructure of substantially only serpentine fibrils. In at least oneembodiment, the fluoropolymer membranes include a plurality ofserpentine fibrils. As used herein, the phrase “plurality of serpentinefibrils” is meant to denote the presence of 2 or more, 5 or more, 10 ormore, or 15 or more serpentine fibrils in the fluoropolymer membranewithin a field of view as taught below. The serpentine fibrils have awidth of about 1.0 micron or less, and in some embodiments, about 0.5microns or less. In one embodiment, the serpentine fibrils have a widthfrom about 0.1 to about 1.0 microns, or from about 0.1 to about 0.5microns. The precursor membrane may or may not be amorphously locked.The precursor membrane may also be at least partially filled, coated, orotherwise combined with additional materials.

The precursor membrane may be restrained in one or more directionsduring the retraction process in order to prescribe the desired amountof elongation of the final article. The amount of elongation is directlyrelated to, and determined by, the amount of retraction.

In one embodiment, retraction can be achieved in a uniaxial tenter frameby positioning the rails at a distance less than the width of theprecursor membrane prior to the application of heat or solvent or both.When using a biaxial tenter frame, one or both of the sets of grips,pins, or other suitable attachment means can similarly be positioned ata distance less than the dimensions of the precursor membrane. It is tobe appreciated that these retraction means differ from the mechanicalcompression taught by the House and Sowinski patents noted above.

The precursor membranes described above can be imbibed with anelastomeric material prior, during, or subsequent to retraction to forma composite. The term “imbibed or imbibing” as used herein is meant todescribe any means for at least partially filling at least a portion ofthe pores of a porous material such as ePTFE or the like. The term “allor at least a portion of the pores” as used herein is meant to denotethat the elastomer is present in at least a portion of all or nearly allof the pores of the ePTFE membrane. In the absence of such elastomericmaterials, fluoropolymer articles having serpentine fibrils do notexhibit appreciable recovery after elongation. Suitable elastomericmaterials may include, but are not limited to, PMVE-TFE(perfluoromethylvinyl ether-tetrafluoroethylene) copolymers, PAVE-TFE(perfluoro (alkyl vinyl ether)-tetrafluoroethylene) copolymers,silicones, polyurethanes, and the like. It is to be noted that PMVE-TFEand PAVE-TFE are fluoroelastomers. Other fluoroelastomers includesuitable elastomeric materials as identified by those of skill in theart. The resultant retracted article possesses high elongation whilesubstantially retaining the strength properties of the fluoropolymermembrane.

As one exemplary embodiment, a lattice of the type shown in FIGS. 1A and2B having square-shaped openings may be prepared. It is to be understoodthat any shaped openings may be formed in the lattice and thatsquare-shaped openings described herein are merely meant to berepresentative. To form such a lattice, a mandrel may be wrapped with anelastomeric composite material, such as the elastomeric compositematerial described below in Example 7. The composite material is free ofwrinkles. The film-mandrel assembly may then be placed into an oven at atemperature of about 320° C. for about 12 minutes to bond the layers.After bonding, the assembly may be removed from the oven and permittedto cool at room temperature to provide an ePTFE tube. Next, a pattern ofregular square openings may be cut into the ePTFE tube, such as with aCO₂ laser. The openings can have a size less than about 2.0 mm, about1.0 mm, or about 0.5 mm. Additionally, the width of the lattice segmentsmay be greater than about 0.01 mm or about 0.05 mm (see FIG. 1B). Thissquare shaped lattice may then be placed into a convection oven at about370° C. for approximately 12 minutes. During heating, the materialshrinks to form squares that can be approximately 2.0 mm, about 1.0 mm,or about 0.5 mm, respectively, in diameter and inscribed circle andlattice segments that can be approximately 0.01 mm or approximately 0.05mm wide, respectively. It is to be appreciated that any suitable meansfor attaching the elastomeric composite material to a stent or othersupport structure may be used and is considered to be within the scopeof the invention.

A lattice made with the elastomeric composite material can be designedto be extended or elongated longitudinally or radially. In addition, thelattice may be expanded and contracted radially without creating foldswhich drape into the lumen. For instance, the lattice can beover-distended, such as when an over-sized catheter is placed throughit, and the composite material will return (contract) without wrinklingor folding. For purposes of this invention, the entire device isconsidered to be “wrinkle-free” if within a 1 cm length of the device,the graft portion is devoid of wrinkles and folds when viewed by thenaked eye. It is to be noted that 1 cm length of the device should beused unless the entire length of the device is less than 1 cm. In thatinstance, the entire device should be utilized to determine if thedevice is “wrinkle-free”. It is to be noted that the terms “free offolds”, “devoid of folds”, and “fold free” are used interchangeablyherein.

Once the serpentine fibrils in the elastomeric composite material areextended to a substantially straight orientation, the strength of thefluoropolymer membrane is substantially that of the originalfluoropolymer membrane. Also, the elastomeric composite material can beelongated at a relatively low tensile stress until reaching a point atwhich a high tensile stress is required for further elongation. Further,the composite material exhibits high elongation while substantiallyretaining the strength properties of the fluoropolymer membrane.Additionally, with longitudinal elongation, a lattice covered stent canbend in a tight radius without the inner diameter of curvature buckling.

Further, should a stent graft be implanted undersized, no folds arepresent in the lattice covering. Additionally, if needed, the coveredstent may be expanded beyond the nominal stent diameter. The ability ofthe lattice covering to remain wrinkle-free results in less or nomaterial infolding, which, in turn, permits the covered stent device tohave a smaller profile (e.g., a reduction in delivery profile of atleast 1 Fr).

Having generally described this invention, a further understanding canbe obtained by reference to certain specific examples illustrated belowwhich are provided for purposes of illustration only and are notintended to be all inclusive or limiting unless otherwise specified.

These methods of using the stent disclosed herein are exemplary and notlimiting. Further uses will be recognized by a skilled artisan.

Testing Methods

It should be understood that although certain methods and equipment aredescribed below, any method or equipment determined suitable by one ofordinary skill in the art may be alternatively utilized.

Mass, Thickness, and Density

Membrane samples are die cut to form rectangular sections about 2.54 cmby about 15.24 cm to measure the weight (using a Mettler-Toledoanalytical balance model AG204) and thickness (using a Käfer Fz1000/30snap gauge). Using these data, density is calculated with the followingformula: ρ=m/(w*l*t), in which: ρ=density (g/cm³), m=mass (g), w=width(cm), l=length (cm), and t=thickness (cm). The average of threemeasurements is reported.

Matrix Tensile Strength (MTS) of Membranes

Tensile break load is measured using an INSTRON 122 tensile test machineequipped with flat-faced grips and a 0.445 kN load cell. The gaugelength is about 5.08 cm and the cross-head speed is about 50.8 cm/min.The sample dimensions are about 2.54 cm by about 15.24 cm. For higheststrength measurements, the longer dimension of the sample is oriented inthe highest strength direction. For the orthogonal MTS measurements, thelarger dimension of the sample is oriented perpendicular to the higheststrength direction. Each sample is weighed using a Mettler Toledo ScaleModel AG204, then the thickness is measured using the Käfer FZ1000/30snap gauge; alternatively, any suitable means for measuring thicknessmay be used. The samples are then tested individually on the tensiletester. Three different sections of each sample are measured. Theaverage of the three maximum loads (i.e., peak force) measurements isreported. The longitudinal and transverse matrix tensile strengths (MTS)are calculated using the following equation: MTS=(maximumload/cross-section area)*(bulk density of PTFE)/(density of the porousmembrane), where the bulk density of the PTFE is taken to be about 2.2g/cm³.

Elongation Testing

Elongation of the retracted article can be measured by any suitableapplication of tensile force, such as, for example, by the use of atensile testing machine, by hand, or by applying internal pressure to atubular article. In the instant invention, elongation is performed at arate of about 10% per second in all directions that are elongated.Elongation is calculated as the final length minus the initial length,divided by the initial length, and is reported as a percentage.

Scanning Electron Microscopy

Scanning electron micrographs are created choosing magnificationssuitable for identifying fibrils. Articles that have been retracted inaccordance with the teachings of invention may require elongation in thedirection of retraction in order to identify the serpentine fibrils. Forthe purposes of identifying the number of serpentine fibrils, a field ofview of 7 microns by 7 microns of the sample is to be employed.

In addition, for the purpose of characterizing fibril width,measurements should be made for serpentine fibrils that aresubstantially separated from each other and do not band together orotherwise form series of fibrils paralleling each other within themembrane. To determine the fibril width, a line is drawn through the SEMimage to bisect it. The SEM image should be of sufficient magnificationsuch that at least 5 serpentine fibrils and not more than 20 serpentinefibrils are clearly visible within the SEM image. Starting from one edgeof the bisected image, the width of the first five consecutiveserpentine fibrils that intersect the bisecting line are measured. Themeasurements are made where the fibril intersects the bisecting line.Next, the five measurements are averaged and the average measurement isrecorded.

Removal of Elastomer from a Lattice Material

For lattice materials containing elastomer, the elastomer can bedissolved or degraded and rinsed away using an appropriate solvent inorder to measure or examine desired properties.

For instance, the fluoroelastomer component of a lattice material can bepartially or substantially removed to enable SEM imaging of the ePTFEstructure. The samples are submerged in 95 g of Fluorinert ElectronicLiquid FC-72 (3M Inc., St. Paul, Minn.) and allowed to soak withoutagitation. After approximately one hour, the fluorinated solvent ispoured off and replaced with 95 g of fresh solvent. This process isrepeated for a total of 5 soaking cycles, the first 4 cycles forapproximately 1 hour, and the 5th cycle for approximately 24 hours.Alternatively, to aid in the removal of elastomer, the sample can alsobe agitated using an ultrasonic cleaner (e.g. Branson 200 UltrasonicCleaner (Model-B200)).

EXAMPLES Example 1

A lattice of the type shown in FIGS. 1A and 2B with square-shapedopenings is prepared. A mandrel is wrapped with an ePTFE film with adiscontinuous FEP coating to a thickness of approximately 0.05 mm. Thefilm-mandrel assembly is placed into an oven at 320° C. for 12 minutesto bond the layers. The assembly is removed from the oven and allowed tocool at room temperature to provide an ePTFE tube. Using a CO₂ laser, apattern of regular square openings is cut into the tube. The openingsare square-shaped with a size of less than about 0.5 mm. The width ofthe lattice segments is greater than about 0.05 mm (see FIG. 1B). Theprepared square shaped lattice is placed in a convection oven set at370° C. for 12 minutes. The material shrinks during heating to formsquares that are approximately 0.5 mm diameter inscribed circle andlattice segments that are approximately 0.05 mm wide.

Example 2

A lattice of the type shown in FIGS. 1B and 2C with diamond-shapedopenings is prepared. An oversized mandrel that is approximately 25%larger than the nominal stent diameter is wrapped with an ePTFE filmwith a discontinuous FEP coating to a thickness of approximately 0.05mm.

The film-mandrel assembly is placed into an oven at 320° C. for 12minutes to bond the layers. The assembly is removed from the oven andallowed to cool at room temperature to provide an ePTFE tube. Using aCO₂ laser, a pattern of slits approximately 40% longer than the finalinscribed circle diameter are oriented transverse to the longitudinalaxis of the mandrel are cut into the tube. The tube with slits isremoved from the mandrel and tensioned over the nominal stent diametermandrel and the slits open to form diamond shapes. The tube ends aretemporarily fixed to length on the mandrel by ePTFE tape. The assemblyis then placed into a convection oven set at 370° C. for 12 minutes. Thematerial shrinks to form diamonds that are approximately 0.5 mm diameterinscribed circle and lattice segments are approximately 0.05 mm wide.

Example 3

A stent is powder coated with a thin layer of FEP powder (DuPont® FEPFluoropolymer Resin, Product Type 5101) in a tabletop blender withinwhich the stent is suspended. After the stent is placed within theblender with FEP powder, the blender is activated. The powder dispersesinto the volume of the blender chamber and the stent is powder coated.After approximately 3 seconds, the stent is removed, and is placed intoa convection oven set at 320° C. for 5 minutes. After this time, thestent is removed and allowed to air cool.

The stent is then placed on a mandrel having an outer diameterapproximately equal to the inner diameter of the stent. The mandrel iscovered on its outer diameter with polyimide film. To temporarily fixthe stent to the mandrel, the stent is placed in a convection oven setat 320° C. for 4 minutes.

After removal from the oven and cooling of the stent and mandrelassembly, a square-shaped opening lattice according to Example 1 iscoaxially positioned over the stent.

The lattice is axially tensioned over the stent and comes in fullcontact with the outer diameter of the stent. The covering ends aretemporarily fixed to length on the mandrel by ePTFE tape. A temporarylayer of ePTFE film is then tightly wrapped around the assembly. Theperforated covering is then placed within a convection oven set at 320°C. oven for 12 minutes to adhere the covering to the stent. Afterremoval from the oven and being allowed to cool to ambient temperature,the temporary film wrapping is removed, and the stent and latticecovering are removed from the mandrel. The lattice is then trimmed flushwith the end of the stent.

Example 4

The stent is powder coated as described in Example 3 above. The prepareddiamond-shaped opening lattice of Example 2 is coaxially positioned overthe stent. The lattice is axially tensioned over the stent, causing itto decrease in diameter and to come in full contact with the outerdiameter of the stent. The lattice ends are temporarily fixed to lengthon the mandrel by ePTFE tape. A temporary layer of ePTFE film is thentightly wrapped around the assembly. The lattice is then placed within aconvection oven set at 320° C. oven for 12 minutes. After removal fromthe oven and being allowed to cool to ambient temperature, the temporaryfilm wrapping is removed, and the stent and lattice covering are removedfrom the mandrel. The lattice is then trimmed flush with the end of thestent.

Example 5

A lattice of the type shown in FIGS. 5A-5C and 6A-6C with square-shapedopenings and varied length segments is prepared. A mandrel is wrappedwith an ePTFE film with a discontinuous FEP coating to a thickness ofapproximately 0.05 mm. The film-mandrel assembly is placed into an ovenat 320° C. for 12 minutes to bond the layers. The assembly is removedfrom the oven and allowed to cool at room temperature to provide anePTFE tube. Using a CO₂ laser, (1) a pattern of irregular parallelogramopenings is cut into the tube (see FIGS. 5A and 6A). The openings areshaped to provide segments with no excess length or with some excesslength, e.g., segment with no bends, one bend, or two bends. Theopenings have a size of less than about 0.5 mm in one dimension and lessthan about 0.17 mm in the second dimension. The width of the latticesegments is greater than about 0.05 mm (see FIG. 1B). The preparedlattice is placed in a convection oven set at 370° C. for 12 minutes.The material shrinks during heating to form parallelograms with orwithout excess length that are approximately 0.5 mm in the longdimension and 0.17 in the short dimension and lattice segments that areapproximately 0.05 mm wide.

Example 6

A drug-eluting lattice of the type shown in FIGS. 9A and 10 withsquare-shaped openings is prepared. A mandrel is wrapped with an ePTFEfilm with a discontinuous FEP coating to a thickness of approximately0.05 mm with at least one reservoir layer comprising a therapeuticagent. Using a CO₂ laser, a pattern of regular square openings is cutinto the tube. During laser cutting, the FEP used in manufacture of amulti-layer lattice, reflows and seals the inner walls of the openingsholding the therapeutic agent within the reservoir layer. The openingsare square-shaped with a size of less than about 0.5 mm. The preparedsquare shaped lattice is placed in a convection oven set at 370° C. for12 minutes. The material shrinks during heating to form squares that areapproximately 0.5 mm diameter inscribed circle and lattice segments thatare approximately 0.05 mm wide.

Example 7

An exemplary elastomeric composite material was made in the followingmanner.

Precursor Membrane

A biaxially expanded ePTFE membrane that had been amorphously locked andhad the following properties was obtained: thickness=0.002 mm,density=0.837 g/cc, matrix tensile strength in the strongestdirection=475 MPa, matrix tensile strength in the direction orthogonalto the strongest direction=390 MPa, elongation at maximum load in thestrongest direction=68%, and elongation at maximum load in the directionorthogonal to the strongest direction=86%. Upon tensioning by hand, themembrane did not noticeably retract upon the release of the tension.

Retracted Membrane

A roll of precursor membrane, wherein the length direction correspondedwith the weakest direction of the membrane, was restrained in the clampsof a heated, uniaxial tenter frame and fed into the heated chamber ofthe tenter frame. The oven temperature was set to about 270° C. Therails of the tenter frame within the heated chamber were angled inwardin order to allow membrane shrinkage to about 39% of its original widthin response to the heat. The line speed was set to provide a dwell timeof about 1.5 minutes within the heated chamber.

The initial and final widths of the membrane were 1625 mm and 632 mm,respectively. The retracted membrane had the following properties:thickness=0.003 mm, density=1.36 g/cc, matrix tensile strength in thestrongest direction of the precursor membrane=158 MPa, matrix tensilestrength in the direction orthogonal to the strongest direction of theprecursor membrane=409 MPa, elongation at maximum load in strongestdirection of the precursor membrane=301%, and elongation at maximum loadin the direction orthogonal to the strongest direction of the precursormembrane=85%.

Extruded Elastomer

A copolymer comprising tetrafluoroethylene (TFE) and perfluoro(methylvinylether) (PMVE) as described in U.S. Pat. No. 7,049,380 to Chang, etal. was obtained with a PMVE/TFE ratio of 2:1. The copolymer wasextruded at about 350° C. into a thin film. The film had the followingproperties: thickness=0.025 mm and width=115 mm.

Elastomeric Composite Material

The extruded elastomer was fed onto the surface of the retractedmembrane and spooled with a 0.064 mm thick high density polyethylenerelease film. The elastomeric composite material had the followingproperties: thickness=0.033 mm and width=115 mm.

The fibrils of the membrane were noted to have a serpentine shape asshown in FIG. 15, a scanning electron micrograph of the surface of anelastomeric composite material with the copolymer removed taken at10,000×.

In addition to being directed to the teachings described above andclaimed below, devices and/or methods having different combinations ofthe features described above and claimed below are contemplated. Assuch, the description is also directed to other devices and/or methodshaving any other possible combination of the dependent features claimedbelow.

Numerous characteristics and advantages have been set forth in thepreceding description, including various alternatives together withdetails of the structure and function of the devices and/or methods. Thedisclosure is intended as illustrative only and as such is not intendedto be exhaustive. It will be evident to those skilled in the art thatvarious modifications may be made, especially in matters of structure,materials, elements, components, shape, size and arrangement of partsincluding combinations within the principles of the invention, to thefull extent indicated by the broad, general meaning of the terms inwhich the appended claims are expressed. To the extent that thesevarious modifications do not depart from the spirit and scope of theappended claims, they are intended to be encompassed therein.

What is claimed is:
 1. A lattice comprising: a generally tubular memberhaving a plurality of segments arranged to define a plurality ofopenings therein, the tubular member having a luminal surface and anopposite exterior surface, wherein at least said plurality of segmentsof said tubular member comprises a composite material including at leastone fluoropolymer membrane and an elastomer, wherein said at least onefluoropolymer membrane is configured in a retracted state such that thefluoropolymer membrane includes a microstructure comprising serpentinefibrils and is characterized by an absence of visible pleating, folding,or wrinkling of the fluoropolymer membrane, and wherein each of saidserpentine fibrils has a width of 1.0 micron or less, the tubular memberbeing transitionable from a reduced diameter in which the serpentinefibrils define a plurality of curved sections and an expanded diameterin which the serpentine fibrils define a substantially straightorientation, the tubular member being more resistant to furtherexpansion once the expanded diameter is achieved.
 2. The lattice ofclaim 1, wherein each of said serpentine fibrils has a width of 0.5micron or less.
 3. The lattice of claim 1, wherein said elastomer ispresent in pores of said at least one fluoropolymer membrane.
 4. Thelattice of claim 1, wherein said elastomer is selected from the groupconsisting of perfluoromethylvinyl ether-tetrafluoroethylene copolymers,perfluoro (alkyl vinyl ether)-tetrafluoroethylene copolymers, siliconesand polyurethanes.
 5. The lattice of claim 1, wherein said at least onefluoropolymer comprises expanded polytetrafluoroethylene.
 6. The latticeof claim 1, wherein said at least one fluoropolymer membrane comprisespores and said elastomer is present in substantially all of the pores.7. The lattice of claim 1, wherein said at least one fluoropolymermembrane comprises a microstructure of substantially only fibrils. 8.The lattice of claim 1, wherein said at least one fluoropolymer membranecomprises a microstructure of substantially only serpentine fibrils. 9.The lattice of claim 1, wherein said openings each have a size of lessthan about 2 mm.
 10. A lattice comprising: a generally tubular memberhaving a plurality of segments arranged to define a plurality ofopenings therein, the tubular member having a luminal surface and anopposite exterior surface, wherein at least said plurality of segmentsof said tubular member comprises a composite material including at leastone fluoropolymer membrane and an elastomer, said at least onefluoropolymer membrane having undergone controlled retraction such thatthe fluoropolymer membrane includes a microstructure comprising fibrilsand is characterized by an absence of visible pleating, folding, orwrinkling of the fluoropolymer membrane, and wherein each of saidfibrils has a width of 1.0 micron or less, wherein said fibrils areserpentine and extend longitudinally in a first direction and in asecond direction different than the first direction, the tubular memberbeing wrinkle free at a reduced diameter and at an expanded diameter.11. The lattice of claim 10, wherein each of said serpentine fibrils hasa width of 0.5 micron or less.
 12. The lattice of claim 10, wherein saidelastomer is present in pores of said at least one fluoropolymermembrane.
 13. The lattice of claim 10, wherein said elastomer isselected from the group consisting of perfluoromethylvinylether-tetrafluoroethylene copolymers, perfluoro (alkyl vinylether)-tetrafluoroethylene copolymers, silicones and polyurethanes. 14.The lattice of claim 10, wherein said at least one fluoropolymercomprises expanded polytetrafluoroethylene.
 15. The lattice of claim 10,wherein said at least one fluoropolymer membrane comprises pores andsaid elastomer is present in substantially all of the pores.
 16. Thelattice of claim 10, wherein said at least one fluoropolymer membranecomprises a microstructure of substantially only fibrils.
 17. Thelattice of claim 10, wherein said at least one fluoropolymer membranecomprises a microstructure of substantially only serpentine fibrils. 18.The lattice of claim 10, wherein said openings each have a size of lessthan about 2 mm.